Diver Ear, Nose and Throat Barotrauma Epidemiology

Last updated: October 5, 2021
Sponsor: Direction Centrale du Service de Santé des Armées
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hearing Loss

Treatment

N/A

Clinical Study ID

NCT04647591
2020PRI07
2020-A02893-36
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. One study related to recreational diving reports that ENT barotrauma concern 10% of dives with experimented divers and 30% with novice divers. Nevertheless, a low number of studies were realized on ENT barotrauma, particularly those involving middle ear and sinuses, maybe because most of them evolve favorably without sequelae.

Besides, it has been described that pathologies which may induce chronic or acute tubal dyspermeability can result in an increased middle ear or sinus barotrauma risk. But once again no study was realized which objective was to look for an association between these risk factors and for the association strength between risk factors and ENT barotrauma occurrence. Few data on military population exist either. However, operational constraints, stressing environment with necessity of realizing performances to validate diving certificate or other military diving specificities can lead one to think that military divers have an increased risk to be subjected to ENT barotrauma. Furthermore, therapeutic measures and more particularly physicians' attitude concerning a temporary incapacity period to avoid recurrence or clinical worsening of barotrauma differ depending on diving centers. But the question to resume diving or not is essential for military staff given that temporary incapacity may lead to training cessation or can be questioned because of operational constraints requiring anticipated diving resumption.

The purpose of this research is to study middle ear and sinus barotrauma thanks to questionnaires focused on those pathologies and their potential risk factors. The hypothesis is that it will allow identification of main risk factors in order to develop preventive measures as well as the characteristics and missions of concerned divers and the impact of those barotrauma on this population.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • French military professional diver of French army diver following diving training (this includes navy, land forces, police, air force, army health service)
  • 18 year or older man or woman

Exclusion

Exclusion Criteria:

  • Diver opposing his study participation
  • Diver who doesn't master enough French language reading or understanding to be able tooppose his study participation
  • Every other reason which, according to investigator, might interfere with theassessment of research outcomes
  • Diver being part of special forces

Study Design

Total Participants: 200
Study Start date:
October 04, 2021
Estimated Completion Date:
October 31, 2024

Study Description

Ear, nose and throat barotrauma are the most frequently encountered accidents during diving. It has been described that pathologies which may induce chronic or acute tubal dyspermeability can result in an increased middle ear or sinus barotrauma risk. But no study was realized which objective was to look for an association between these risk factors and for the association strength between risk factors and ENT barotrauma occurrence.

Futhermore, few data on military population exist while operational constraints, stressing environment with necessity of realizing performances to validate diving certificate or other military diving specificities can lead one to think that military divers have an increased risk to be subjected to ENT barotrauma. Therapeutic measures and more particularly physicians' attitude concerning a temporary incapacity period to avoid recurrence or clinical worsening of barotrauma differ depending on diving centers. But the question to resume diving or not is essential for military staff given that temporary incapacity may lead to training cessation or can be questioned because of operational constraints requiring anticipated diving resumption.

The aim of this research is then to study middle ear and sinus barotrauma in order to identify main risk factors, the characteristics and missions of concerned military divers and the impact of those pathologies on this population. Two kind of questionnaires will be used : one which will be completed by divers just after their inclusion in the study and one that will be filled in case of ENT barotrauma suspicion over a period of two years. The first questionnaire will give information about diving level and medical history and the second one will allow standardized assessment of barotrauma suspicion . Divers will be followed for two years, whether they experience an ENT barotrauma or not.

Connect with a study center

  • 160e Antenne Médicale d'Antibes

    Antibes, Alpes Maritimes 06606
    France

    Active - Recruiting

  • 2nd Groupe Plongeurs Démineurs Brest

    Brest, Finistère 29240
    France

    Active - Recruiting

  • 1er Groupe Plongeurs Démineurs Cherbourg

    Cherbourg, Manche 50115
    France

    Active - Recruiting

  • 152e Antenne Médicale de St Mandrier

    Toulon, Var 83800
    France

    Active - Recruiting

  • 3e Groupe Plongeurs Démineurs Toulon

    Toulon, Var 83800
    France

    Active - Recruiting

  • Base navale de Toulon

    Toulon, Var 83800
    France

    Active - Recruiting

  • Service de médecine hyperbare et expertise de la plongée

    Toulon, Var 83800
    France

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.